NCT07603804Recruiting
Accelerated iTBS for Major Depression
Investigation of the Relationship Between Changes in Neurobiological Biomarkers After Accelerated Transcranial Magnetic Stimulation Treatment and Treatment Response in Patients With Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
Major depressive disorder (MDD) is a common and disabling psychiatric condition, and many patients do not achieve adequate response to standard antidepressant treatments. Accelerated intermittent theta burst stimulation (iTBS) is a promising neuromodulation approach that may provide rapid antidepressant effects. This prospective interventional study aims to evaluate the clinical effectiveness of accelerated bilateral dorsomedial prefrontal cortex iTBS in patients with MDD and to investigate treatment-related changes in neurobiological biomarkers, including cortisol, ACTH, BDNF, IL-1β, IL-6, TNF-α, and CRP. Associations between biomarker changes and treatment response will also be examined.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 8 Mar 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Istanbul University - Cerrahpasa
- Diseases
- Depression
- NCT number
- NCT07603804
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 8 Mar 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of metal implants in the head or neck region
- Cochlear implants
- Previous neurosurgical procedures
- Use of medications that may significantly affect neuroendocrine or inflammatory markers (e.g., corticosteroids, immunomodulators)
Other illness
- History of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic depression
- Current substance use disorder
- Neurological disorders that may affect brain function (e.g., epilepsy, multiple sclerosis, dementia, Parkinson's disease)
- History of epileptic seizures
- Cardiac pacemaker or implanted electronic devices
- History of deep brain stimulation or vagus nerve stimulation
- Endocrine disorders affecting the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome, Addison's disease, thyroid disorders)
- Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, Hashimoto thyroiditis)
- Recent surgery or acute infection
Other
- Severe head trauma
- Pregnancy or breastfeeding
- Active suicidal crisis, severe agitation, or inability to comply with study procedures
Who the study is looking for
- Age between 18 and 65 years
- Diagnosis of Major Depressive Disorder according to DSM-5 criteria
- Inadequate response to at least one adequate antidepressant treatment trial
- Hamilton Depression Rating Scale (HAM-D) score ≥14 at baseline
- Stable dose of antidepressant medication for at least 4 weeks prior to study entry
- Ability to provide written informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| İstanbul University-Cerrahpaşa Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.